D-1154-2022 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- June 29, 2022
- Initiation Date
- June 10, 2022
- Termination Date
- July 25, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 47,500 vials
Product Description
Testosterone Cypionate Injection, USP, 200 mg/mL, 1 mL Single-dose vial per carton, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512; Manufactured by: Sun Pharmaceutical Industries Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India, NDC 62756-015-40.
Reason for Recall
Lack of Assurance of Sterility: Manufacturing deviation which was reported due to a microbial excursion
Distribution Pattern
Nationwide within the United States
Code Information
Lot: HAC3427A, EXP Date: 08/2023